PRIMAL BLENDS ADVANCED MOISTURIZING GEL SANITIZER- alcohol solution

Primal blends advanced moisturizing gel sanitizer by

Drug Labeling and Warnings

Primal blends advanced moisturizing gel sanitizer by is a Otc medication manufactured, distributed, or labeled by Alchemy Nutra LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 80% v/v.

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease.
• recommended for repeated use

Warnings

For external use only: hands

Flammable. Keep away from fire or flame

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin.
• do not inhale or ingest.

Stop using and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping.
• for children under 6, use only under adult supervision.
• not recommended for infants.

Other Information

• do not store above 105°F.
• may discolor some fabrics.
• not recommended for infants.

Inactive ingredients

Purified water, Glycerin, Hydroxypropyl Cellulose, Vitamin E

Package Label - Principal Display Panel

59 mL

118 mL

3785 mL

INGREDIENTS AND APPEARANCE

PRIMAL BLENDS ADVANCED MOISTURIZING GEL SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75494-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75494-006-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/25/2020
2	NDC: 75494-006-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/25/2020
3	NDC: 75494-006-03	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2020

Labeler - Alchemy Nutra LLC (117481753)

Establishment
Name	Address	ID/FEI	Business Operations
Alchemy Nutra LLC		117481753	manufacture(75494-006)